Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension

NCT ID: NCT03041441

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2019-10-26

Brief Summary

The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment of this condition.

Detailed Description

Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is listed in Appendix 1. All research scans are performed without intravenous contrast. Approximate scan time per session will be 20-22 minutes.

Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan. Estimated values of CSF pressure derived from MRI will be compared to values measured during lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat research MRI after epidural patching will be performed to assess for differences in pre- and post-treatment scans.

Conditions

Intracranial Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRICP method

MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure.

Group Type: EXPERIMENTAL

MRI algorithm

Intervention Type: DEVICE

MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion

Lumbar puncture

Intervention Type: PROCEDURE

Lumbar puncture according to the standard-of-care treatment plan.

Epidural patching

Intervention Type: PROCEDURE

Epidural patching will be performed to the standard-of -care treatment plan

Interventions

MRI algorithm

MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion

Intervention Type: DEVICE

Lumbar puncture

Lumbar puncture according to the standard-of-care treatment plan.

Intervention Type: PROCEDURE

Epidural patching

Epidural patching will be performed to the standard-of -care treatment plan

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Known diagnosis of intracranial hypotension, established by the following criteria: the presence of orthostatic headache, and one or more of the following criteria: prior CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior spine imaging, or cranial MRI changes of intracranial hypotension.15
• Ability to provide informed consent.
• Expected ability to complete standard-of-care procedures (lumbar puncture and epidural patching)

Exclusion Criteria

• Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.)
• Severe claustrophobia or other condition requiring the need for anxiolysis, sedation, or any other medication for MRI scanning
• Inability or expected inability to complete study interventions as scheduled
• Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic reaction to required medication, lack of vascular access, etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kranz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Pro00078211

Identifier Type: -

Identifier Source: org_study_id